INNOVANCE® D-Dimer Controls OPDY09
GUDID 00842768023668
INNOVANCE® D-Dimer Control 1 and Control 2 are assayed, normal and pathological level, intralaboratory quality controls for assessment of precision and analytical bias in the quantitative determination of D-dimer on Siemens and Sysmex® Systems
Siemens Healthcare Diagnostics Products GmbH
D-dimer IVD, control| Primary Device ID | 00842768023668 |
| NIH Device Record Key | 09d6729a-309a-43da-8b68-8ab44e6196d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INNOVANCE® D-Dimer Controls |
| Version Model Number | 10446006 |
| Catalog Number | OPDY09 |
| Company DUNS | 388240673 |
| Company Name | Siemens Healthcare Diagnostics Products GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
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| Phone | +1(800)242-3233 |
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| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| XX@XX.XX | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(800)242-3233 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00842768023668 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K081732
FDA Product Code
| DAP | FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
Devices Manufactured by Siemens Healthcare Diagnostics Products GmbH
| 00630414240336 - INNOVANCE Apixaban Controls | 2024-12-04 INNOVANCE Apixaban Controls |
| 00630414240343 - INNOVANCE Apixaban Standards | 2024-12-04 INNOVANCE Apixaban Standards |
| 00630414240404 - INNOVANCE Anti-Xa | 2024-12-04 In-vitro diagnostic automated assay for the quantitative determination of UFH and LMWH activity in human citrated plasma. |
| 00842768018800 - BC von Willebrand Reagent | 2024-09-20 Determination of ristocetin co-factor activity of von Willebrand factor in human plasma through platelet agglutination |
| 00842768019661 - LA 2 Confirmation Reagent | 2024-04-08 LA 2 Confirmation Reagent. Phospholipid-rich DRVV reagent for the specific correction of Lupus Anticoagulants |
| 00842768019654 - LA 1 Screening Reagent | 2024-04-08 LA 1 Screening Reagent. Simplified DRVV reagent to screen for the presence of Lupus Anticoagulants |
| 00842768019678 - LA Control Low | 2024-04-08 LA Control Low is a low positive control plasma for use in Lupus Anticoagulant clotting test assays |
| 00842768019685 - LA Control High | 2024-04-08 LA Control High is a high positive control plasma for use in Lupus Anticoagulant clotting test assays |
Trademark Results [INNOVANCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INNOVANCE 97178063 not registered Live/Pending |
WESCO Distribution, Inc. 2021-12-17 |
 INNOVANCE 90346939 not registered Live/Pending |
YANTAI WINHERE AUTO-PART MANUFACTURING CO.,LTD. 2020-11-29 |
 INNOVANCE 90071044 not registered Live/Pending |
GL Biotech Inc. 2020-07-24 |
 INNOVANCE 88659375 not registered Live/Pending |
Prota Biotech Inc 2019-10-18 |
 INNOVANCE 87247972 not registered Dead/Abandoned |
Innova Biotech, Inc. 2016-11-25 |
 INNOVANCE 78283931 3527541 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTSGMBH 2003-08-06 |
 INNOVANCE 76584588 3159425 Live/Registered |
Innovance, Inc. 2004-04-02 |
 INNOVANCE 76580855 not registered Dead/Abandoned |
Dade Behring Marburg GmbH 2004-03-15 |
 INNOVANCE 76217932 not registered Dead/Abandoned |
Innovance, Inc. 2001-03-01 |
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